Pazopanib Hydrochloride in Treating Patients With Advanced Angiosarcoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01462630|
Recruitment Status : Recruiting
First Posted : October 31, 2011
Last Update Posted : February 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Adult Angiosarcoma Recurrent Adult Soft Tissue Sarcoma Stage III Adult Soft Tissue Sarcoma Stage IV Adult Soft Tissue Sarcoma||Drug: pazopanib hydrochloride Other: laboratory biomarker analysis Procedure: positron emission tomography Procedure: computed tomography Radiation: fludeoxyglucose F 18||Phase 2|
I. To determine the progression free survival (PFS) at 3 months and response rate defined as complete response (CR) and partial response (PR) in angiosarcoma patients treated with pazopanib.
I. To assess overall survival of patients treated with pazopanib. II. To gather more safety data for pazopanib in this patient population. III. To explore the ability of [F-18] fludeoxyglucose (FDG) (positron emission tomography [PET])/computed tomography (CT) imaging to assess response.
Patients receive pazopanib hydrochloride orally (PO) once daily (QD). Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study Evaluating the Role of Pazopanib in Angiosarcoma|
|Actual Study Start Date :||November 3, 2011|
|Estimated Primary Completion Date :||December 15, 2018|
|Estimated Study Completion Date :||December 15, 2020|
Experimental: Treatment (enzyme inhibitor therapy)
Patients receive pazopanib hydrochloride PO QD. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Drug: pazopanib hydrochloride
Other: laboratory biomarker analysis
Procedure: positron emission tomography
Procedure: computed tomography
Other Name: tomography, computed
Radiation: fludeoxyglucose F 18
- PFS [ Time Frame: 3 months ]Estimated using the method of Kaplan and Meier.
- Response rate defined as CR and PR in angiosarcoma patients treated with pazopanib hydrochloride [ Time Frame: 3 months ]Standard estimates of the binomial proportion will be used to estimate and place confidence bounds on the several response rates.
- Overall survival of patients treated with pazopanib hydrochloride [ Time Frame: Up to 2 years ]Estimated using the method of Kaplan and Meier.
- Evaluation of toxicity and safety for pazopanib hydrochloride in this patient population [ Time Frame: Up to 2 years ]
- [F-18] FDG PET/CT as an imaging agent in predicting efficacy or early response as compared with CT imaging [ Time Frame: Up to 2 years ]Descriptive statistics will include mean, SD, median, minimum, and maximum for continuous variables and the numbers and percentages for categorical variables. Summary statistics for changes in SUVs, tumor to background ratios, lesion size, and comparison scores will be analyzed and presented.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01462630
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Contact: Mark Agulnik 312-695-1222 firstname.lastname@example.org|
|Principal Investigator: Mark Agulnik|
|United States, Michigan|
|University of Michigan||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Contact: Scott M. Schuetze 734-615-0654 email@example.com|
|Principal Investigator: Scott M. Schuetze|
|United States, Pennsylvania|
|Fox Chase Cancer Center||Recruiting|
|Philadelphia, Pennsylvania, United States, 19111-2497|
|Contact: Margaret von Mehren 215-728-2460 firstname.lastname@example.org|
|Principal Investigator: Margaret von Mehren|
|United States, South Carolina|
|Hollings Cancer Center Medical University of South Carolina||Terminated|
|Charleston, South Carolina, United States, 29425|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Vinod Ravi 713-792-3626 email@example.com|
|Principal Investigator: Vinod Ravi|
|Principal Investigator:||Margaret von Mehren||Fox Chase Cancer Center|